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BARDA pledges up to $483m for Moderna's COVID-19 vaccine work

BARDA pledges up to $483m for Moderna's COVID-19 vaccine work

April 20, 2020

The Biomedical Advanced Research and Development Authority (BARDA) is pledging up to $483 million to accelerate the development of Moderna’s experimental COVID-19 vaccine, an infusion of money that the Cambridge, Massachusetts, biotech company says will allow it to manufacture the yet-to-be approved product around the clock, seven days a week.

Moderna’s chief executive, Stephane Bancel, said Thursday that the money will enable the company to supply “millions of doses per month in 2020 ― and with further investments, tens of millions per month in 2021 ― if the vaccine candidate is successful in the clinic."

“We are thankful for BARDA’s support to fund the accelerated development of mRNA-1273, our vaccine candidate," Bancel said. “Time is of the essence to provide a vaccine against this pandemic virus.” BARDA is part of the US Department of Health and Human Services.

The National Institutes of Health has completed enrollment for an early-stage clinical trial of Moderna’s experimental vaccine, which was the first potential vaccine to go to trial. It relies on custom-built messenger RNA to produce an immune response. Forty-five healthy volunteers between the age of 18 and 55 began getting doses on March 16 in Seattle. The NIH recently broadened the first phase of the trial to include three groups of participants ages 51 to 70, and three groups of those 71 and older. Enrollment in those studies is ongoing.

If the vaccine proves safe and appears to work, Moderna plans to begin a mid-stage trial in the second quarter of this year, and then, if all goes well with that testing, the company would start a late-stage trial in the fall — the last step before seeking approval from the Food and Drug Administration, which would be expected to act quickly on any vaccine proven to work.

"Preparing now for advanced stage clinical trials and production scale-up while the Phase 1 [trial] is underway could shave months off development of COVID-19 vaccines,” said Rick Bright, BARDA's director.

Moderna says it expects to hire up to 150 new employees in the United States so the company can expand manufacturing from two shifts a day, five days a week, to three shifts a day, seven days a week. Moderna has a $130 million plant in Norwood, Massachusetts.